Automatic lead lock for an implantable medical device

ABSTRACT

Disclosed herein is an implantable medical device including a housing, a header, a connector port, and a collet assembly. The header can be arranged with the housing. The connector port can be arranged within the header and configured to couple an implantable lead to the header. The collet assembly can be arranged within the connector port and configured to frictionally engage a portion of the implantable lead and to secure the implantable lead with the header in response to insertion of the portion of the implantable lead into the connector port.

CROSS REFERENCE TO RELATED APPLICATION

This application claims priority to Provisional Application No.63/070,469, filed Aug. 26, 2020, which is herein incorporated byreference in its entirety.

TECHNICAL FIELD

The present disclosure relates to an implantable system having animplantable lead and a connector port. More specifically, the disclosurerelates to releasably securing of the implantable lead within theconnector port.

BACKGROUND

Implantable medical systems may include an implantable lead assembly andan implantable pulse generator connected with the implantable leadassembly. Further, a header of the implantable pulse generator generallyincludes corresponding connector ports to effectively couple the leadassembly with the implantable pulse generator. A proper connectionbetween the implantable leads and the corresponding connector ports isrequired to allow proper functioning of the implantable system. The leadassembly and the implantable pulse generator are to remain connectedafter implantation to ensure desired functionality.

SUMMARY

According to embodiments of the present disclosure, in a first example,an implantable medical device including a housing, a header, a connectorport, and a collet assembly. The header can be arranged with thehousing. The connector port can be arranged within the header andconfigured to couple an implantable lead to the header. The colletassembly can be arranged within the connector port and configured tofrictionally engage a portion of the implantable lead and to secure theimplantable lead with the header in response to insertion of the portionof the implantable lead into the connector port.

In some such examples, the collet assembly or a portion thereof includesan angled outer circumference, an inner surface of the connector port ora portion thereof includes an angled inner circumference, or both. Thecollet assembly can include one or more bearings arranged about acircumference of the collet assembly and configured to contact an innersurface of the connector port.

In some such examples, the collet assembly can be configured to clampdown on the portion of the implantable lead in response to insertion ofthe portion of the implantable lead into the connector port. The colletassembly can be split at a portion of a circumference thereof.

In another example, an implantable medical device comprising can includea housing, a header, a connector port, and a collet assembly. The headercan be arranged with the housing. The connector port can be arrangedwithin the header and configured to couple an implantable lead to theheader. The collet assembly can be arranged within the connector portand configured to clamp against a portion of the implantable lead and tosecure the implantable lead with the header in response to insertion ofthe portion of the implantable lead into the connector port.

In another example, an implantable medical device comprising can includea housing, a header, a connector port, and a collet assembly. The headercan be arranged with the housing. The connector port can be arrangedwithin the header and configured to couple an implantable lead to theheader. The collet assembly including one or more bearings arrangedabout a circumference of the collet assembly, the one or more bearingsconfigured to contact an inner surface of the connector port arrangedwithin the connector port and configured to frictionally engage aportion of the implantable lead and to secure the implantable lead withthe header in response to insertion of the portion of the implantablelead into the connector port.

In another example, a method of coupling an implantable lead to animplantable medical device. The method can include coupling theimplantable lead to the implantable medical device by moving theimplantable lead in a first direction into a connector port arrangedwithin a header of the implantable medical device. The method caninclude engaging and securing a portion of the implantable lead with acollet assembly arranged within the connector port in response toinsertion of the portion of the implantable lead into the connectorport.

While multiple embodiments are disclosed, still other embodiments of thepresent invention will become apparent to those skilled in the art fromthe following detailed description, which shows and describesillustrative embodiments of the invention. Accordingly, the drawings anddetailed description are to be regarded as illustrative in nature andnot restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an illustration of an example implantable system forstimulating a target location on or within the heart, in accordance withvarious aspects of the present disclosure.

FIG. 2 is a perspective view of an illustration of an example connectorport and collet assembly, in accordance with various aspects of thepresent disclosure.

FIG. 3 is a perspective exploded view of an illustration of an exampleconnector port and collet assembly, in accordance with various aspectsof the present disclosure.

FIG. 4 is a perspective view of an illustration of another exampleconnector port and collet assembly, in accordance with various aspectsof the present disclosure.

FIG. 5 is a perspective exploded view of an illustration of anotherexample connector port and collet assembly, in accordance with variousaspects of the present disclosure.

FIG. 6 is a flowchart of a method, in accordance with various aspects ofthe present disclosure.

While the invention is amenable to various modifications and alternativeforms, specific embodiments have been shown by way of example in thedrawings and are described in detail below. The intention, however, isnot to limit the invention to the particular embodiments described. Onthe contrary, the invention is intended to cover all modifications,equivalents, and alternatives falling within the scope of the inventionas defined by the appended claims.

DETAILED DESCRIPTION

FIG. 1 is a schematic illustration of an implantable system 100 forstimulating a target location 102 on or within the heart. As shown, theimplantable system 100 includes an implantable medical device (IMD) 104and an implantable lead assembly 106 connected to the IMD 104. Invarious embodiments, the IMD 104 is an implantable pulse generatoradapted to generate electrical signals to be delivered to the targetlocation 102 for pacing and/or for sensing electrical activity at alocation on or within the heart. The IMD 104 can include microprocessorsto provide processing, evaluation, and to deliver electrical shocks andpulses of different energy levels and timing for defibrillation,cardioversion, and pacing to a heart in response to cardiac arrhythmiaincluding fibrillation, tachycardia, heart failure, and bradycardia. Inother instances, the implantable system 100 can also be suitable for usewith implantable electrical stimulators, such as, but not limited to,neuro-stimulators, skeletal stimulators, central nervous systemstimulators, or stimulators for the treatment of pain.

The IMD 104 may include one or more connector ports 110, 112. In certaininstances, the IMD (e.g., pulse generator 104) includes a header 108with the connector port(s) 110, 112. As shown, for example, the header108 includes a first connector port 110 and a second connector port 112.In addition, the implantable lead assembly 106 includes a firstimplantable lead 120 connected to the first connector port 110 and asecond implantable lead 122 connected to the second connector port 112.In some instances, the implantable lead assembly 106 may also include athird implantable lead (not shown) and the header 108 may include acorresponding third connector port (not shown).

Each of the first and second implantable leads 120, 122 includes aflexible lead body, a plurality of conductor wires, a plurality ofelectrodes, and a terminal connector assembly (as shown in detail, forexample, with reference to FIGS. 5-6 ). For example, as shown, the firstimplantable lead 120 includes a flexible lead body 130 having a proximalend 132, a distal end portion 134, and a plurality of conductor lumens136 extending axially within the lead body 130 from the proximal end 132to the distal end portion 134. The first implantable lead 120 alsoincludes a plurality of conductor wires 138, each conductor wireextending within one of the conductor lumens 136 in the lead body 130.The first implantable lead 120 further includes a plurality ofelectrodes 140 coupled to the distal end portion 134 of the lead body130. Each of the electrodes 140 are electrically coupled to at least oneof the plurality of conductor wires 138. The first implantable lead 120also includes a terminal connector assembly 142 (or terminal pin)coupled to the proximal end 132 of the lead body 130. The terminalconnector assembly 142 is sized to be inserted into and received by thefirst connector port 110 of the header 108.

Similarly, the second implantable lead 122 includes a flexible lead body150 having a proximal end 152, a distal end portion 154, and a pluralityof conductor lumens 156 extending axially within the lead body 150 fromthe proximal end 152 to the distal end portion 154. The secondimplantable lead 122 also includes a plurality of conductor wires 158,each conductor wire extending within one of the conductor lumens 156 inthe lead body 150. Further, the second implantable lead 122 includes aplurality of electrodes 160 coupled to the distal end portion 154 of thelead body 150. Each of the electrodes 160 are electrically coupled to atleast one of the plurality of conductor wires 158. The secondimplantable lead 122 also includes a terminal connector assembly 162coupled to the proximal end 152 of the lead body 150. The terminalconnector assembly 162 is sized to be inserted into and received by thesecond connector port 112 of the header 108.

As an example of implant locations for one or more leads, the firstimplantable lead 120 is shown extending into a right ventricle of theheart, and the second implantable lead 122 extending through thecoronary sinus and into a coronary vein disposed outside the leftventricle of the heart. The electrical signals and stimuli conveyed bythe IMD 104 are carried to the electrode at the distal end of the leadby the conductors. The IMD 104 is typically implanted subcutaneouslywithin an implantation location or pocket in the patient's chest orabdomen.

The IMD 104 and lead(s) 120, 122 are connected by a physician. In orderto maintain the implantable leads 120, 122 connected to the IMD 104, theheader 108 may include a mechanism (e.g., a collet assembly) thatsecures the lead(s) 120, 122 in place. As used herein, a collet assemblycan refer to a number of subsystems such as a ball, roller, and/or camwith a basing member. A number of balls, rollers, and/or cams can becaptured in a collet and a biasing member may engage the collet toensure location accuracy of the collet assembly. In a first example, thecollet assembly can generally act as a container for the balls, rollers,and/or cams. In a second example, the collet assembly can be one or morecollets and can have a friction bias between the implantable leads 120,122 and the one or more collets. In this way, a higher friction existsbetween the implantable leads 120, 122 and the one or more collets thanbetween the housing and the one or more collets. This friction bias canbe achieved by one or more methods, including but not limited to surfacetopology optimization, coatings, or having a roller, ball, and/or cambetween the collet and housing. As used hereinafter, collet assembly mayrefer to any of the aforementioned examples, including the first andsecond examples. In addition, the securement mechanism may bereleasable, in certain instances, to allow for manipulation orreplacement of the lead(s) 120, 122. The securement mechanism may lessenthe ability for the lead(s) 120, 122 to be removed or back out of theheader 108, without intentional intervention by the physician, after thelead(s) 120, 122 have been connected. Further yet, the securementmechanism does not require any additional tool or tooling (e.g., a setscrew) for connection of the lead(s) 120, 122 to the header 108.

FIG. 2 is a perspective view of an illustration of an example connectorport 200 and collet assembly 210, in accordance with various aspects ofthe present disclosure. The connector port 200 may be arranged within aheader that forms a portion of a housing of an implantable medicaldevice as shown above with reference to FIG. 1 . The connector port 200,arranged within the header, is configured to couple an implantable leadto the header (and to the implantable medical device).

In certain instances, the collet assembly 210 may include an angledouter circumference 212, and an inner surface 206 of the connector port200 may include an angled inner circumference 207. In some examples, atleast one of the angled outer circumference 212 and the angled innercircumference 207 can extend along the entire circumference of thecollet assembly 210 and inner surface 206 respectively or can extendalong one or more partial portions thereof. This arrangement may beadvantageous in the collet assembly 210 securing the implantable lead inthe connector port 200 by, for example, maintaining compressive forceson a portion of the implantable lead. In certain instances, theconnector port 200 may include a proximal end 132 and a distal end 201with the collet assembly 210 being arranged between the proximal end 132and the distal end 201 of the connector port 200.

With inclusion of one or more bearings 214, the collet assembly 210 maymove or translate within the connector port 200. In certain instances,the collet assembly 210 may include one or more bearings 214 arrangedabout a circumference of the collet assembly 210. The one or morebearings 214 may be configured to contact an inner surface 206 of theconnector port 200. In certain instances, the one or more bearings 214may include three or more bearings 214. The collet assembly 210 havingmultiple bearings 214 may centrally or symmetrically align the colletassembly 210 within the connector port 200. The one or more bearings 214may take a variety of forms, such as a bearing ball or a rolling needle.Any number (e.g., one, two, three, etc.) or size of bearings 214discussed herein should not be interpreted to limit the number ofbearings 214 that may be included in the present disclosure. There maybe an odd number of bearings 214 in some instances while in otherinstances there may be an even number of bearings 214. The one or morebearings 214 may facilitate movement of the collet assembly 210 withinthe connector port 200.The collet assembly 210 may only be held inposition or constrained in the direction opposite to a direction ofinsertion of the implantable lead. Under these circumstances, the colletassembly 210 may otherwise be free to rotate, axially translate, orradially translate within the connector assembly, within tolerances.

In any of these examples, the one or more bearings 214 may allow thecollet assembly 210 to be movable within the connector port 200 suchthat the one or more bearings 214 may translate toward or away from adistal end 201 of the connector port 200 in response to insertion of aportion of an implantable lead within the connector port 200.

A portion (e.g., a terminal pin) of the implantable lead may be insertedinto the connector port 200 at an opening 208 therein by movement in adirection from the proximal end 132 to the distal end 201. Under thesecircumstances, a portion of the implantable lead that is inserted intothe connector port 200 may be received and frictionally engaged by thecollet assembly 210. During insertion, the one or more bearings 214 maytranslate along the implantable lead as the implantable lead isprogressively received within the collet assembly 210 (e.g., up until adistal end of the implantable lead contacts the distal end 201 of theconnector port 200). As such, the portion of the implantable lead mayengage the one or more bearings 214 of the collet assembly 210. Whenengaged, the one or more bearings 214 may cause the collet assembly 210to inhibit movement of the portion of the implantable lead in one ormore directions relative to the collet assembly 210. The one or morebearings 214 may inhibit axial movement of the implantable lead withinthe collet assembly 210 in at least one direction such that the portionof the implantable lead is secured within the connector port 200. Theone or more bearings 214 of the collet assembly 210 may be configured tomaintain the portion of the implantable lead within the connector port200 in response to forces acting on the implantable lead in a directiongenerally from the distal end 201 toward the proximal end 203. Afterinsertion, the implantable lead is removably secured within theconnector port 200.

In certain instances, the one or more bearings 214 may frictionallyengage the portion of the implantable lead after insertion into theconnector port 200 and the angled inner circumference 207 of theconnector port 200.When the one or more bearings 214 frictionally engagethe portion of the implantable lead, the one or more bearings 214 maycause the collet assembly 210 to move in the same direction (thedirection of insertion of the portion of the implantable lead into theconnector port 200). The one or more bearings 214 reduce the frictionbetween the implantable lead and the collet while maintaining contactwith the portion of implantable lead. During insertion, the implantablelead may move further distally than the collet assembly 210. In certaininstances, the one or more bearings 214 may translate toward a distalend 201 of the connector port 200 in response to insertion of theportion of the implantable lead into the connector port 200. Afterinsertion, the one or more bearings 214 may translate away from thedistal end 201 of the connector port 200.In response to insertion, theangled inner circumference 207 of the connector port 200 can facilitatemovement of the collet assembly 210 toward the proximal end 132 of theconnector port 200 as the one or more bearings 214 engage the angledinner circumference 207 thereby exerting compressive or radially inwardforces on the portion the implantable lead arranged within the colletassembly 210.

Arrangement of the one or more bearings 214 about the collet assembly210 may take numerous forms. For example, arrangement of the one or morebearings 214 may be varied circumferentially, axially, and radially. Incertain instances, the one or more bearings 214 may include a pluralityof bearings 214. The plurality of bearings 214 may be spaced equallyabout the circumference of the collet assembly 210. In another instance,the plurality of bearings 214 may be spaced variedly about thecircumference of the collet assembly 210. With regards to axialarrangements, each bearing in the plurality of bearings 214 may bearranged in plane with each other, for example, at a plane extendingthrough a circumference of the collet assembly 210. In other instances,a number (e.g., one, two, three, etc.) of bearings 214 in the pluralityof bearings 214 may be out of plane with the other (e.g., one, two,three, etc.) bearings 214 in the plurality of bearings 214. With regardsto radial arrangements, similarly, each bearing in the plurality ofbearings 214 may be equally radially spaced from a central axis of thecollet assembly 210 or, on the other hand, may be variedly radiallyspaced from a central axis of the collet assembly 210. In any of theseexamples, the one or more bearings 214 may be arranged such that they donot detrimentally contact certain features of the connector port 200(e.g., an access hole 250 for removing the implantable leads asdiscussed further hereinafter).

As noted above and in certain instances, the one or more bearings 214may be forced against the portion of the implantable lead and a portionof an inner surface 206 of the connector port 200 such as the angledinner circumference 207 along which the one or more bearings 214 maytranslate. In this way, as the one or more bearings 214 are forced in adirection from a distal end 201 of the connector port 200 to a proximalend 132 of the connector port 200, the one or more bearings 214 mayforcibly engage or collapse toward and engage the portion of theimplantable lead. In certain instances, the one or more bearings 214 maybe configured to contact the portion of the implantable lead and theinner surface 206 of the connector port 200 with substantially equalforces. In certain instances, the one or more bearings 214 may maintaincompressive forces acting on the portion of the implantable lead inresponse to the forces acting on the implantable lead in a directiongenerally from the distal end 201 toward the proximal end 203. Underthese circumstances, a magnitude of the compressive forces may beproportional to a magnitude of the forces acting on the implantable leadin a direction generally from the distal end 201 toward the proximal end203.

In certain instances, the collet assembly 210 may be biased toward oneend of the connector port 200. The collet assembly 210 may be biasedtoward the proximal end 203 of the connector port 200. In this manner, alocation of the collet assembly 210, prior to the portion of theimplantable lead being inserted into the collet assembly 210, may bemaintained near or adjacent to the proximal end 203 of the connectorport 200. In other instances, the collet assembly 210 may be positionedcloser the distal end 201 of the connector port 200 than the proximalend 203 of the connector port 200.

A biasing member 220 may bias the collet assembly 210 in the connectorport 200. The biasing member 220 may be a spring 222 (e.g., a coiledaxial or torsional spring 222), a washer (e.g., planar or split), andthe like, and may include any number of biasing members. For example,and in certain instances, the biasing member 220 may be a spring 222arranged at or adjacent to the distal end 201 of the connector port 200(e.g., between the collet assembly 210 and the end cap 204). The spring222 may be configured to bias the collet assembly 210 toward theproximal end 203 of the connector port 200. The spring 222 may maintaina position of the collet assembly 210 and oppose the insertion force ofthe portion of the implantable lead into the collet assembly 210. Thespring 222 may force the collet assembly 210, and more particularly theone or more bearings 214 of the collet assembly 210, to engage with theangled inner circumference 207 of the connector port 200 such that thecollet assembly 210 collapses against and secures the portion of theimplantable lead within the collet assembly 210.

The spring 222 may maintain engagement between the one or more bearings214 of the collet assembly 210 and the angled inner circumference 207 ofthe connector port 200 to releasably secure the portion of theimplantable lead within the collet assembly 210. The portion of theimplantable lead may be released by moving the collet assembly 210toward the distal end 201 of the connector port 200 (e.g., by using atool as described further hereinafter). The spring 222 may only compressas much as required to maintain at least a portion of the colletassembly 210 proximal to the proximal end 203 of the connector port 200during insertion. As such, when force is removed from the implantablelead after insertion, the spring 222 may again cause the one or morebearings 214 of the collet assembly 210 to engage with the angled innercircumference 207 of the connector port 200.

As noted above, the collet assembly 210 may be configured to removepressure from the implantable lead in response to a tool moving thecollet assembly 210 toward a distal end 201 of the connector port 200through an opening 208 in the connector port 200. As the tool moves thecollet assembly 210 in this way, the collet assembly 210 may open orrelease forces on the portion of the implantable lead to allow theportion of the implantable lead to be removed. In examples, the tool maybe a component that is configured to cause the collet assembly 210 tomove toward the distal end 201 of the connector port 200. The tool maybe an external tool (e.g., a probe) or an internal tool (e.g., anactuator such as a button with a mounted probe or molded piece) and maybe configured to removable engage the collet assembly 210 (e.g., at atip of the probe) through an access hole 250. For example, as discussedfurther hereinafter, the probe may have a profiled tip (e.g., rounded,flat, etc.) configured to engage a portion of the collet assembly 210.

FIG. 3 is a perspective exploded view of an illustration of an exampleconnector port and collet assembly 210, in accordance with variousaspects of the present disclosure. As with previously discussedexamples, the IMD shown here may include a housing, a header arrangedwith the housing, a connector port 200, and a collet assembly 210. Theconnector port 200 may be arranged within the header and configured tocouple an implantable lead to the header. The collet assembly 210 may bearranged within the connector port 200 and may include one or morebearings 214 arranged about a circumference of the collet assembly 210.When the collet assembly 210 includes one or more bearings 214 arrangedabout a circumference of the collet assembly 210, as shown here, the oneor more bearings 214 may be configured to contact an inner surface 206of the connector port 200 arranged within the connector port 200 andconfigured to frictionally engage a portion of the implantable lead andto secure the implantable lead with the header in response to insertionof the portion of the implantable lead into the connector port 200.

In this example, as can be seen, the one or more bearings 214 may beconfigured to contact both the inner surface 206 of the connector port200 and the implantable lead. Both a cross section of the angled outercircumference 212 of the collet assembly 210 and a cross section of theangled inner circumference 207 of the connector port 200 are tapered ina direction from a distal end 201 of the collet assembly 210 to aproximal end 203 of the collet assembly 210. In certain instances, theangle is between approximately 0.5 degrees and approximately 35 degrees.In contacting the implantable lead, some or each of the bearings 214 inthe one or more bearings 214 may protrude through both ends of a bearingaperture 340 corresponding thereto. The bearing aperture(s) 340 areconfigured to house the each of the bearings 214 when the connector port200 is assembled. In certain instances, some or each of the bearings 214in the one or more bearings 214 may protrude through the aperture suchthat the one or more bearings 214 are allowed to further protrude intoan inner-surface end of the aperture with force applied generally in theradially inward direction of the collet. Under these circumstances, thecollet assembly 210 may be arranged within the connector port 200 andconfigured to cause the one or more bearings 214 to clamp against aportion of the implantable lead and to secure the implantable lead withthe header in response to insertion of the portion of the implantablelead into the connector port 200. Such a sequence (and similar sequencesdiscussed herein) may be characterized as automatically locking theimplantable lead to the connector port 200.

The IMD may inhibit release of the implantable lead once the portion ofthe implantable lead is arranged within the collet assembly 210 or bypulling the implantable lead out of the connector port 200.The colletassembly 210 may exert forces on the portion of the implantable leadthat is frictionally engaged with the one or more bearings 214. As notedabove, the one or more bearings 214 may maintain compressive forcesacting on the portion of the implantable lead in response to the forcesacting on the implantable lead in a direction generally from the distalend 201 toward the proximal end 203. In certain instances, the one ormore bearings 214 may secure the implantable lead with the header suchthat the implantable lead is secured with the header when the one ormore bearings 214 translate toward a proximal end 203 of the connectorport 200 in response to forces acting opposite to those of insertion ofthe implantable lead into the connector port 200 (e.g., pulling forces).Under these circumstances, the one or more bearings 214 may maintaincompressive forces on the implantable lead that are proportional to theforces acting on the implantable lead in a direction generally from thedistal end 201 toward the proximal end 203. For example, increasedpulling forces will result in proportionally increased clamping forcesto ensure that the implantable lead stays secured to the connector port200. In this way, unintentional removal of the implantable lead may belimited.

Release of the implantable lead may require a tool or additionalintervention. In certain instances, a proximal end of the angled outercircumference 212 may be configured to accommodate engagement of a probeto release the implantable lead from the collet assembly 210 asdiscussed further elsewhere herein. For example, the proximal end of theangled outer circumference 212 may be chamfered or beveled such that thechamfer or bevel are aligned with the access hole 250 through which theprobe may protrude to engage the angled outer surface. In this way,axial motion of the collet assembly 210 toward the distal end 201 of theconnector port 200 may by way of radially inward motion of the probe(e.g., in a downward direction radially inward of the outercircumferential surface) may be facilitated by contacting the chamfer orbevel with the probe. It should be noted that the probe may have amatching chamfer or bevel at the tip thereof or may be a blunt, rounded,or standard tip while maintaining similar operation. The probe may alsooperate by levering or otherwise causing the collet to move toward thedistal end 201 of the connector port 200. In addition, or inalternative, the implantable lead may be released via a torque releasemechanism. In examples, a torque release mechanism may be a camconfigured to connector port 200 such that access with a tool through250 would facilitate rotation of the cam, pushing collet 210 toward thedistal end 201. In other examples, the torque release mechanism may besimilar to the aforementioned tool, such as a torque wrench, amolded-in-place button or pin assembly, forceps, or any other mechanismthat can cause the collet assembly to move toward the distal end 201 ofthe connector port 200.

FIG. 4 is a perspective view of an illustration of another exampleconnector port 400 and collet assembly 410, in accordance with variousaspects of the present disclosure. The connector port 400 may bearranged within a header that forms a portion of a housing of animplantable medical device as shown above with reference to FIG. 1 .Like the connector port 200, the connector port 400, arranged within theheader, is configured to couple an implantable lead 460 to the header(and to the implantable medical device). In certain instances, theconnector port 400 may include an end cap 404. Like the collet assembly210, the collet assembly 410 may be arranged within the connector portand may be configured to frictionally engage a portion of theimplantable lead 460 and secure the implantable with the header inresponse to insertion of the portion of the implantable lead 460 intothe connector port.

The collet assembly 410 may resemble those collet assemblies discussedelsewhere herein. For example, the collet assembly 410 shown hereincludes an angled outer circumference 412 and an inner surface 406 ofthe connector port 400 includes an angled inner circumference 407. Eachof the angled outer circumference 412 and the angled inner circumference407 may have an angle that is approximately the same as the other. Botha cross section of the angled outer circumference 412 of the colletassembly 410 and a cross section of the angled inner circumference 407of the connector port 400 are tapered in a direction from a distal endof the collet assembly 410 to a proximal end of the collet assembly410.The angle may be between approximately 0.5 degrees and approximately35 degrees. As with previously discussed examples, geometry of theconnector port 400 and the collet assembly 410 may facilitate the colletassembly 410 frictionally engaging and securing the implantable lead 460with the header. And such an arrangement may be advantageous in thecollet assembly 410 securing the implantable lead 460 in the connectorport 400 (e.g., by maintaining compressive forces on a portion of theimplantable lead 460). The connector port 400 may include a proximal end403 and a distal end 401 with the collet assembly 410 being arrangedbetween the proximal end 403 and the distal end 401 of the connectorport 400.

As with previous example, this example of the collet assembly 410 mayinclude one or more bearings 414 arranged about a circumference of thecollet assembly 410 and configured to contact an inner surface 406 ofthe connector port 400. The one or more bearings 414 translate toward adistal end 401 of the connector port 400 in response to insertion of theportion of the implantable lead 460 into the connector port 400. The oneor more bearings 414 include a plurality of bearings 414 spaced equallyabout the circumference of the collet assembly 410. In contacting theinner surface 406 of the connector port 400 during operation, thesebearings 414 may exert forces on the implantable lead 460. The one ormore bearings 414 of the collet assembly 410 may be configured tomaintain the portion of the implantable lead 460 within the connectorport 400 in response to forces acting on the implantable lead 460 in adirection generally from the distal end 401 toward the proximal end 403.The one or more bearings 414 maintain compressive forces acting on theportion of the implantable lead 460 in response to the forces acting onthe implantable lead 460 in a direction generally from the distal end401 toward the proximal end 403.

With this example, the combination of the one or more bearings 414 and asplit construction of the collet assembly 410 may allow the colletassembly 410 (e.g., in addition to or instead of the one or morebearings 414) to frictionally engage the implantable lead 460. Incertain instances, the collet assembly 410 may be configured to clampdown on the portion of the implantable lead 460 in response to insertionof the portion of the implantable lead 460 into the connector port 400.In this case, the one or more bearings 414 reduce the friction betweenthe connector port 400 and the collet. In certain instances, the colletassembly 410 may be split 480 at a portion of a circumference thereof.In certain instances, the collet assembly 410 may be split at more thanone portion of a circumference thereof. In any of these instances, thesplit 480 may be configured to open and close to thereby allow the innerdiameter of the collet assembly 410 to change (e.g., increase ordecrease) within limits. In this way, the collet assembly may compriseeither a single collet or a multiple-member collet that clamps down onthe portion of the implantable lead 460 and may have a frictionimbalance such that a higher friction exists between the implantableleads 460 and the collet assembly 410 than between the connector port400 and the collet assembly 410. For example, the collet assembly 410may have a first inner diameter when in a resting position and may havea second inner diameter that is smaller than the first inner diameter asthe collect assembly experiences compressive forces. As the split 480closes, an inner surface 470 a collet 411 of the collet assembly 410 maybe brought into contact or into further contact with the implantablelead 460.

In certain instances, the collet assembly 410 includes an angled outercircumference 412 and an inner surface 406 of the connector port 400includes an angled inner circumference 407. An angle of the angled outercircumference 412 of the collet assembly 410 may be approximately equalto an angle of the angled inner circumference 407 of the connector port400. In this way, the angled outer circumference 412 and the angledinner circumference 407 may be complementary such that movement of thecollet assembly 410 between the proximal and distal ends of theconnector port 400 may be free from interference at certain points. Andat other points (e.g., when the one or more bearings 414 translate alongthe angled inner circumference), movement of the collet assembly 410between the proximal and distal ends of the connector port 400 maycorrespondingly cause the collet assembly 410 to experience compressiveforces. Under these circumstances, the split may correspondingly open asthe one or more bearings 414 translate along the angled inner surfacetoward the distal end of the connector port 400 and close as the one ormore bearings 414 translate along the angled inner surface toward theproximal end 403 of the connector port 400.

The collet assembly 410 may be biasedly arranged (e.g., via a biasingmember 420) within the connector port 400 as with previously-discussedexamples. In certain instances, the connector port 400 may include aproximal end 403 and a distal end with the collet assembly 410 beingarranged between the proximal end 403 and the distal end of theconnector port 400 and the collet assembly 410 biased toward theproximal end 403 of the connector port 400. The collet assembly 410 maybe positioned closer the proximal end 403 of the connector port 400 thanthe distal end of the connector port 400. In certain instances, the IMDmay include a biasing member 420 in the form of a spring 422 arranged atthe distal end of the connector port 400 configured to bias the colletassembly 410 toward the proximal end 403 of the connector port 400. Aswith examples previously discussed herein, releasing the implantablelead 460 from the collet assembly 410 may require a tool. For example,releasing the implantable lead 460 may require moving the colletassembly 410 toward the distal end of the connector port 400 relative tothe implantable lead 460. In certain instances, the collet assembly 410may be configured to remove pressure from the implantable lead 460 inresponse to a tool moving the collet assembly 410 toward a distal end ofthe connector port 400 through an opening in the connector port 400. Inaddition, or in alternative, the implantable lead 460 may be releasedvia a torque release mechanism.

FIG. 5 is a perspective exploded view of an illustration of anotherexample connector port and collet assembly 410, in accordance withvarious aspects of the present disclosure. As with the previous example,the connector port may be arranged within a header that forms a portionof a housing of an implantable medical device as shown above withreference to FIG. 1 . The connector port, arranged within the header, isconfigured to couple an implantable lead 460 to the header (and to theimplantable medical device). The collet assembly 410 may be arrangedwithin the connector port and may be configured to clamp against aportion of the implantable lead 460 and to secure the implantable withthe header in response to insertion of the portion of the implantablelead 460 into the connector port.

As discussed in detail above, in this example, the one or more bearings414 may be configured to contact both the inner surface of the connectorport and the implantable lead 460. The collet assembly 410, as opposedto the bearings 414, clamps against the implantable lead 460 to securethe implantable lead 460 to the connector port. As noted prior, both across section of the angled outer circumference of the collet assembly410 and a cross section of the angled inner circumference of theconnector port are tapered in a direction from a distal end of thecollet assembly 410 to a proximal end of the collet assembly 410. Theangle may be between approximately 0.5 degrees and approximately 35degrees. In contacting the implantable lead 460, some or each of thebearings 414 in the one or more bearings 414 may protrude through bothends of a bearing aperture corresponding thereto and being configured tohouse the bearing when the connector port is assembled.

FIG. 6 is a flowchart of a method 600, in accordance with variousaspects of the present disclosure. As shown here, the present disclosureincludes a method 600 of coupling an implantable lead to an implantablemedical device. The method 600 may include coupling the implantable leadto the implantable medical device by moving the implantable lead in afirst direction into a connector port arranged within a header of theimplantable medical device at step 602. At steps 604 and 606, the method600 may include engaging and securing a portion of the implantable leadwith a collet assembly arranged within the connector port in response toinsertion of the portion of the implantable lead into the connectorport. In certain instances, engaging and securing the portion of theimplantable lead may include clamping the collet assembly on the portionof the implantable lead in response to insertion of the portion of theimplantable lead into the connector port. In certain instances, engagingand securing the portion of the implantable lead includes forcing one ormore bearings of the collet assembly against the portion of theimplantable lead and a portion of an inner surface of the connectorport.

While shown here as discrete steps, each step of the method can beperformed simultaneously or substantially simultaneously with one ormore other steps. As noted elsewhere herein, the method may includeautomatically securing the implantable lead such that, for example, bothengaging a portion of the implantable lead with a collet assembly atstep 604 and securing a portion of the implantable lead with the colletassembly at step 606 can be performed simultaneously or substantiallysimultaneously. In this way, other than moving the implantable lead in afirst direction into a connector port at step 602, no additional userintervention is required to secure the implantable lead with the colletassembly.

Aspects of the present disclosure, including those discussed in relationto FIGS. 2-6 , provide numerous advantages. For example, typicalapplications of a connector port employ a combination of a tip block, aset screw, and a torque wrench to secure and release an implantablelead. By removing these components, the present disclosure reduces theamount of noise issues in the field from no or under torqued set screws.In addition, usability is improved because the present disclosure allowsfor easy attachment of the implantable lead and because relative axialmotion of the lead within the connector port may be inhibited. As well,the overall design of the IMD may be improved because the need forcertain components (e.g., top mounted seal plugs) may be eliminated. Bysimplifying the design of the retaining mechanism and eliminatingcertain components, the profile of the header may also be improved.Plus, the associated manufacturing process may be simple.

Various modifications and additions can be made to the exemplaryembodiments discussed without departing from the scope of the presentinvention. For example, while the embodiments described above refer toparticular features, the scope of this invention also includesembodiments having different combinations of features and embodimentsthat do not include all of the described features. Accordingly, thescope of the present invention is intended to embrace all suchalternatives, modifications, and variations as fall within the scope ofthe claims, together with all equivalents thereof.

We claim:
 1. An implantable medical device comprising: a housing; and aheader arranged with the housing; a connector port arranged within theheader and configured to couple an implantable lead to the header, theconnector port including a proximal end, an opposite distal end, and anaccess hole extending radially through the connector port between theproximal and distal ends of the connector port; and a collet assemblyarranged within the connector port and configured to clamp against aportion of the implantable lead and to secure the implantable lead withthe header in response to insertion of the portion of the implantablelead into the connector port, wherein the collet assembly includes oneor more bearings arranged about an angled outer circumference of thecollet assembly and configured to contact an angled inner circumferenceof the connector port, wherein the angled outer circumference of thecollet assembly extends from a distal end of the collet assembly to aproximal end of the collet assembly, and wherein the one or morebearings are located between the distal end and the proximal end, andwherein the access hole is aligned with the proximal end of the colletassembly and is configured to receive a probe for engaging the proximalend of the collet assembly to cause the collet assembly to move in anaxial direction toward the distal end of the connector port.
 2. Theimplantable medical device of claim 1, wherein the one or more bearingstranslate toward a distal end of the connector port in response toinsertion of the portion of the implantable lead into the connectorport.
 3. The implantable medical device of claim 2, wherein the one ormore bearings include a plurality of bearings spaced equally about theangled outer circumference of the collet assembly.
 4. The implantablemedical device of claim 1, wherein the collet assembly is split at aportion of the angled outer circumference thereof.
 5. The implantablemedical device of claim 1, wherein an angle of the angled outercircumference of the collet assembly is approximately equal to an angleof the angled inner circumference of the connector port.
 6. Theimplantable medical device of claim 5, wherein both a cross section ofthe angled outer circumference of the collet assembly and a crosssection of the angled inner circumference of the connector port aretapered in a direction from the distal end of the collet assembly to theproximal end of the collet assembly, and wherein the angle is betweenapproximately 0.5 degrees and approximately 35 degrees.
 7. Animplantable medical device comprising: a housing; and a header arrangedwith the housing; a connector port arranged within the header andconfigured to couple an implantable lead to the header, the connectorport including a proximal end, an opposite distal end, and an accesshole extending radially through the connector port between the proximaland distal ends of the connector port; and a collet assembly includingone or more bearings arranged about an angled outer circumference of thecollet assembly, the one or more bearings configured to contact anangled inner circumference of the connector port arranged within theconnector port and configured to frictionally engage a portion of theimplantable lead and to secure the implantable lead with the header inresponse to insertion of the portion of the implantable lead into theconnector port, wherein the angled outer circumference of the colletassembly extends from a distal end of the collet assembly to a proximalend of the collet assembly, and wherein the one or more bearings arelocated between the distal end and the proximal end, and wherein theaccess hole is aligned with the proximal end of the collet assembly andis configured to receive a probe for engaging the proximal end of thecollet assembly to cause the collet assembly to move in an axialdirection toward the distal end of the connector port.
 8. Theimplantable medical device of claim 7, wherein the one or more bearingstranslate toward a distal end of the connector port in response toinsertion of the portion of the implantable lead into the connectorport.
 9. The implantable medical device of claim 7, wherein the one ormore bearings include a plurality of bearings spaced equally about theangled outer circumference of the collet assembly.
 10. The implantablemedical device of claim 7, wherein the one or more bearings are forcedagainst the portion of the implantable lead and a portion of an innersurface of the connector port.
 11. The implantable medical device ofclaim 10, wherein the one or more bearings are configured to contact theportion of the implantable lead and the inner surface of the connectorport with substantially equal forces.
 12. The implantable medical deviceof claim 7, wherein the one or more bearings secure the implantable leadwith the header such that the implantable lead is secured with theheader when the one or more bearings translate toward a proximal end ofthe connector port in response to forces acting opposite to those ofinsertion of the implantable lead into the connector port.